The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorHacettepe University
About this trial
The goal of this clinical trial is to learn if a traditional grape-based fermented drink called hardaliye helps treat fibromyalgia in adult women. We will also learn whether adding hardaliye to a personalized nutrition plan works better than using either one alone.
The main questions are:
Does diet + hardaliye improve antioxidant status and lower oxidative stress more than diet only or hardaliye only? Does diet + hardaliye lower inflammation (TNF-α, IL-6, hs-CRP) and raise SIRT1 levels? Do these changes relate to less pain and better symptoms (fibromyalgia impact, gut symptoms, sleep, mood)? Are there benefits for weight, waist size, blood pressure, and blood lipids?
How the groups are compared:
Researchers will compare three groups for 8 weeks:
Diet + Hardaliye (personalized medical nutrition plan + one 200 mL bottle of hardaliye daily) Diet only (personalized medical nutrition plan) Hardaliye only (usual diet + one 200 mL bottle of hardaliye daily)
Participants will:
Drink one 200 mL bottle of hardaliye each day if assigned to Diet + Hardaliye or Hardaliye only Follow a personalized nutrition plan if assigned to Diet + Hardaliye or Diet only Visit the clinic at the start and end of the study, with brief check-ins around weeks 2, 4, and 6 Give blood samples before and after the 8-week period Complete short questionnaires on pain, fibromyalgia impact, gut symptoms, sleep, and mood Keep simple logs of daily drink intake and diet plan adherence, and report any side effects
Who can join:
Adult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg/m² who meet the study's health and medication criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, 20-40 years
BMI 25.0-29.9 kg/m²
FM per 2016 ACR criteria; abdominal pain/cramp per SSS sub-item
MEDAS ≤5 at screening.
Disqualifiers
Age <20 or >40
BMI ≤24.99 or ≥30.0 kg/m²
Professional athletes; night-shift workers
Food allergies; acute infection; antibiotic use within past month or during intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Medical Nutrition Therapy (MNT)
BehavioralIndividually tailored medical nutrition therapy delivered using a standardized counseling framework, energy prescription derived from predictive equations and physical activity level, with standardized macronutrient targets and follow-up reinforcement per protocol.
Hardaliye (200 mL/day)
Other interventionTraditional grape-based fermented beverage dispensed in 200 mL bottles; participants consume 200 mL once daily for the intervention period with standardized intake instructions and product handling.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Medical Nutrition Therapy + HardaliyeExperimental treatment 2 interventions
Group B: Medical Nutrition TherapyExperimental treatment 1 intervention
Group C: HardaliyeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fibromyalgia Impact Questionnaire Revised
Change in FIQR (0-100); lower scores indicate less symptom burden and better function.
Time frame
Baseline to Week 82
Pain Severity (Visual Analog Scale, VAS)
Change in 0-10 cm VAS for average pain; lower scores reflect less pain.
Time frame
Baseline to Week 83
Gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS)
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score and subscale scores (abdominal pain, reflux, diarrhea, dyspepsia/indigestion, constipation). The GSRS includes 15 items, each rated for the past week on a 7-point scale (1 = no discomfort, 7 = very severe discomfort). Higher scores indicate worse gastrointestinal symptoms and lower scores indicate fewer/milder symptoms. Total score (sum of 15 items): 15-105 Abdominal pain subscale (Items 1, 4, 5; sum): 3-21 Reflux subscale (Items 2, 3; sum): 2-14 Dyspepsia/Indigestion subscale (Items 6, 7, 8, 9; sum): 4-28 Diarrhea subscale (Items 11, 12, 14; sum): 3-21 Constipation subscale (Items 10, 13, 15; sum): 3-21
Time frame
Baseline to Week 84
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Change in PSQI global score (0-21); lower scores indicate better sleep quality.
Time frame
Baseline to Week 8Secondary outcomes
1
Total Antioxidant Status (TAS; μmol Trolox eq/L)
Change in circulating antioxidant capacity; higher values suggest stronger systemic antioxidant defense.
Time frame
Baseline to Week 82
Total Oxidant Status (TOS; μmol H₂O₂ eq/L)
Change in cumulative oxidant load; lower values indicate reduced oxidative pressure.
Time frame
Baseline to Week 83
Oxidative Stress Index (OSI = TOS×100 / TAS)
Ratio index of oxidant burden to antioxidant capacity; lower values denote better redox balance.
Time frame
Baseline to Week 84
Plasma Malondialdehyde (MDA; TBARS method)
Change in lipid peroxidation marker; lower levels indicate less oxidative membrane damage.
Time frame
Baseline to Week 8Other outcomes
1
Body Weight
Body weight measured in light clothing without shoes using a calibrated scale. Units: kilograms (kg). Higher values indicate greater body mass.
Time frame
Baseline to Week 82
Height
Standing height measured without shoes using a calibrated stadiometer. Units: centimeters (cm). Height is collected primarily to compute BMI (kg/m²). Higher values indicate greater stature.
Time frame
Baseline to Week 83
Body Mass Index (BMI)
BMI calculated as weight (kg) / height (m²) using measured weight and height. Units: kg/m². Higher values indicate higher adiposity-related risk.
Time frame
Baseline to Week 84
Waist Circumference
Waist circumference measured at a standardized anatomical site using a non-elastic tape. Units: centimeters (cm). Higher values indicate greater central adiposity.
Time frame
Baseline to Week 8Sponsors and contacts
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Source ClinicalTrials.gov